FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K Number: K002616
·
Decision Dec 11, 2000
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
7
Review Days
111
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Basic Information
- Device Name
- ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
- K Number
- K002616
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electric Mobility, LLC
- Date Received
- August 22, 2000
- Decision Date
- December 11, 2000
- Product Code
- INI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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Other Clearances by Electric Mobility, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K092130 | RASCAL WE GO 250 POWERED WHEELCHAIR | Sep 21, 2009 | Substantially Equivalent |
| K991281 | ELECTRIC MOBILITY CAVALIER SCOOTERS | Oct 27, 1999 | Substantially Equivalent |
| K972370 | RASCAL POWER CHAIR | Nov 14, 1997 | Substantially Equivalent |
| K924515 | ELECTRIC MOBILITY RASCAL | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K882669 | APPOLLO BATH | Jul 8, 1988 | Substantially Equivalent |
| K874739 | ELECTRIC MOBILITY'S SPARKY | Apr 22, 1988 | Substantially Equivalent |